Latest revision as of 23:38, 15 July 2024

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Section editor
	Elizabeth J. Davis, MD Vanderbilt University Nashville, TN, USA

1 regimens on this page 1 variants on this page

Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Bone Cancer.

All lines of therapy

Denosumab monotherapy

Regimen

Study	Dates of enrollment	Evidence
Thomas et. al 2010 (Amgen 20040215)	2006-2008	Phase 2 (RT)
Chawla et al. 2013 (Amgen 20062004)	2008-2011	Phase 2 (RT)

Targeted therapy

Denosumab (Xgeva) as follows:
- Cycle 1: 120 mg SC once per day on days 1, 8, 15
- Cycle 2 onwards: 120 mg SC once on day 1

Supportive therapy

Calcium 500 mg PO once per day
Vitamin D 400 IU PO once per day

28-day cycles

References

Amgen 20040215: Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. Epub 2010 Feb 10. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00396279
Amgen 20062004: Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. Epub 2013 Jul 16. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT00680992
1. Update: Chawla S, Blay JY, Rutkowski P, Le Cesne A, Reichardt P, Gelderblom H, Grimer RJ, Choy E, Skubitz K, Seeger L, Schuetze SM, Henshaw R, Dai T, Jandial D, Palmerini E. Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. Lancet Oncol. 2019 Dec;20(12):1719-1729. Epub 2019 Nov 6. link to original article PubMed

@@ Line 12: / Line 12: @@
 =Guidelines=
 '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
-==[https://www.nccn.org/ NCCN]==
+==NCCN==
 *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1418 NCCN Guidelines - Bone Cancer].''
 =All lines of therapy=
@@ Line 43: / Line 43: @@
 </div></div>
 ===References===
-# '''Amgen 20040215:''' Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. Epub 2010 Feb 10. [https://doi.org/10.1016/S1470-2045(10)70010-3 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20149736/ PubMed] [https://clinicaltrials.gov/study/NCT00396279 NCT00396279]
+# '''Amgen 20040215:''' Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. Epub 2010 Feb 10. [https://doi.org/10.1016/S1470-2045(10)70010-3 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/20149736/ PubMed] [https://clinicaltrials.gov/study/NCT00396279 NCT00396279]
-# '''Amgen 20062004:''' Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. Epub 2013 Jul 16. [https://doi.org/10.1016/S1470-2045(13)70277-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23867211/ PubMed] [https://clinicaltrials.gov/study/NCT00680992 NCT00680992]
+# '''Amgen 20062004:''' Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. Epub 2013 Jul 16. [https://doi.org/10.1016/S1470-2045(13)70277-8 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/23867211/ PubMed] [https://clinicaltrials.gov/study/NCT00680992 NCT00680992]
 ## '''Update:''' Chawla S, Blay JY, Rutkowski P, Le Cesne A, Reichardt P, Gelderblom H, Grimer RJ, Choy E, Skubitz K, Seeger L, Schuetze SM, Henshaw R, Dai T, Jandial D, Palmerini E. Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. Lancet Oncol. 2019 Dec;20(12):1719-1729. Epub 2019 Nov 6. [https://doi.org/10.1016/S1470-2045(19)30663-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31704134/ PubMed]
 [[Category:Giant-cell tumor of bone regimens]]
 [[Category:Disease-specific pages]]
 [[Category:Bone sarcomas]]

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